Skip to main content

Table 1 Primary and secondary study outcomes

From: Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial

Primary outcome Secondary outcomes
Percentage of efficacy (measured as observed RASS = target RASS ±1) - Sedation protocol effectiveness (percentage of ‘protocol violation days’ on the total of ICU days)
  - Delirium- and coma-free days (respectively negative CAM-ICU and RASS ≥ −3 in all daily observations until ICU day 28)
  - Ventilation-free days
  - Nursing evaluation of sedation adequacy (communication skills, cooperation, environment tolerance)
  - Overall ICU and hospital mortality
  - Absolute mortality 1 year after ICU discharge
  - Sedative drug costs
  - Indirect markers of inefficacy and side effects, like prevalence of ‘dangerous episodes’ (self-extubation, removal of other invasive tools), length of ICU and hospital stay, use of anti-psychotic drugs as indirect marker of delirium, indicators of sedation failure (use of physical restraints, antagonists administration like flumazenil or naloxone), sepsis prevalence.